Cleared Traditional

K042315 - CEREBRAL STATE MONITOR - CSM

K042315 is an FDA 510(k) clearance for CEREBRAL STATE MONITOR - CSM, manufactured by Danmeter A/S. The device is a Class 2 Neurology device with product code OLW cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K042315 · Danmeter A/S · Neurology device
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Jan 2005
Decision
148d
Days
Class 2
Risk

K042315 is an FDA 510(k) clearance for the CEREBRAL STATE MONITOR - CSM. Classified as Index-generating Electroencephalograph Software (product code OLW), Class II - Special Controls.

Submitted by Danmeter A/S (Odense C, DK). The FDA issued a Cleared decision on January 21, 2005 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Danmeter A/S devices

FDA 510(k) Submission Details - K042315

510(k) Number K042315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2004
Decision Date January 21, 2005
Days to Decision 148 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 148d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLW Device Classification - Class 2, Special Controls

Product Code OLW Index-generating Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electrical Activity Of The Brain By Transformation Of Electroencephalograph Signals Into A Dimensionless Index Number For Use And Interpretation By A Qualified User.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - OLW Index-generating Electroencephalograph Software

All 14
Devices cleared under the same product code (OLW) and FDA review panel - the closest regulatory comparables to K042315.
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